elevated levels of lipids in the blood hyperlipidemia
Conditions
Interventions
The study will consist of two treatment periods of four weeks with a washout
period of four weeks. Total duration 12 weeks. In one treatment period, Danshen
(3 capsules, orally administered twice da
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age: 40-70 (50% men / 50% women) * Women: - postmenopausal, or - use of contraceptive pill * Hyperlipidemia - elevated level of triglycerides: > 1.7 mmol/L - elevated level of LDL-cholesterol: > 3.5 mmol/L - reduced level of HDL-cholesterol: 90 mm Hg - diastolic pressure > 140 mm Hg * Signed informed consent
Exclusion criteria
Exclusion criteria: * Smoking * Alcohol or drug abuse * History of cardiovascular disease (myocard infarct, angina pectoris, CVA, CI) * Diabetes mellitus * Pregnancy * Concomitant (chronic) use of: - ACE-inhibitors - Statins - Anticoagulant drugs - > 1 antihypertensive drug - High-dose antihypertensive medication (above defined daily dose) - (Antioxidant) vitamin supplements * Clinically significant liver disease (3 times the upper normal limit of ALAT,ASAT,AF, *GT or LDH) * Clinically significant anemia (male Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome parameters will be assessed in the 4th week of each treatment period. To study the effect of Danshen on hyperlipidemia, in particular LDL-cholesterol, but also HDL-cholesterol, total cholesterol, total triglycerides, apolipoprotein B plasma levels and LDL oxidation will be measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure will be quantified by 24-h Ambulatory Blood Pressure Monitoring and office blood pressure monitoring (during 20 min. period). Endothelial function will be assessed by both the forearm vasodilator response to infusion of acetylcholine and nitroprusside into the brachial artery, quantified by venous occlusion strain gauge plethysmography, and by measuring flow-mediated dilatation of the brachial artery by ultrasound. Ischemia-reperfusion injury will be determined by measuring flow-mediated dilatation of the brachial artery after applying increasing periods of forearm ischemia. Furthermore, plasma biomarkers of oxidative stress (e.g. TBARS) and vascular inflammation (e.g. hsCRP) will be sampled. In addition, markers of hemostasis (e.g. von Willebrand factor), and hemorheological parameters, such as blood viscosity, will be determined. Insulin sensitivity will be assessed by use of the QUICKI index. | — |
Countries
Netherlands
Outcome results
None listed